MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERGLIDE; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4520

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

The hyperglide balloon has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the balloon was ruptured when the balloon was prefilled normally in vitro.The device was not used in the patient.The patient was undergoing balloon-assisted coiling treatment for an aneurysm.There were not any patient symptoms or complications associated with this event.

Manufacturer Narrative

The hyperglide occlusion balloon catheter was returned within an opened hyperglide inner pouch and within a dispenser coil.The hyperglide occlusion balloon catheter was returned without its guidewire.The reason for the guidewire not returning was not provided.The hyperglide occlusion balloon catheter was decontaminated.No damages were found within the hyperglide hub.No bends or kinks were found with the hyperglide catheter body.However, what appears to be blood was found within the catheter lumen.No damages were found with the hyperglide balloon/distal tip.The hyperglide occlusion balloon catheter was flushed, blood and water exited from the distal tip.An in-house x-pedion-10 guidewire was hydrated and inserted through the hyperglide occlusion balloon catheter lumen.The balloon was inflated and held inflation.No leaks or ruptures were detected.No other anomalies were observed.Based on the device analysis and reported information, the report of balloon rupture during set up could not be confirmed.No leaks or ruptures were detected upon inflating the hyperglide balloon.In addition, as what appears to be blood was found within the catheter lumen it does not appear the event occurred ¿in vitro¿ as reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYPERGLIDE
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8940654
• MDR Text Key: 180394486
• Report Number: 2029214-2019-00881
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K090728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 104-4520
• Device Lot Number: A683758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR